Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section

Condition(s) studied

Investigational drug(s) / intervention(s)

Intrathecal Morphine: The anesthetist in charge performs spinal anesthesia using a 25-gauge pencil point needle in the sitting position at the L3 to L4 or L4 to L5 interspace. After skin disinfection with 2% alcoholic chlorhexidine solution and skin anesthesia with 2 ml of lidocaine 2%, all patients receive spinal anesthesia with a solution of 2 ml hyper-baric bupivacaine 0.5% (10 mg) and 3 μg of sufentanil while, ITM group adds morphine 30 μg. The patient is not informed about the drugs used in spinal anesthesia.

TAP Block: At the end of surgery, in the TB group a bilateral Transabdominal Plane Block (TAP) block is performed. The anesthetist prepares two sy-ringes with 20 ml each with ropivacaine 0.25% with 75 μg of clonidine. Upon identifying the TAP compart-ment in the lateral abdominal wall (in the midaxillary line between the bony prominences of the subcostal margin and the iliac crest) with the linear high-frequency ultrasound probe, we penetrate the skin with the block needle using an in-plane technique. Upon entering the plane between the internal oblique and the transversus abdominis muscles, and after negative aspiration of blood, the local anesthetic is slowly injected. The TAP compartment begins to separate, hydrodissect, or "unzip" as the local anesthetic is injected, pushing the transversus abdominis muscle down. An injection of 20 ml of the prepared solution is injected for each side. The TAP block is performed behind the operating drape.

Study summary

The goal of this randomized controlled clinical trial is to determine if low-dose intrathecal morphine is superior to a Transversus Abdominis Plane (TAP) block with ropivacaine and clonidine for postoperative analgesia in women aged 18 years or older undergoing elective cesarean section under neuraxial anesthesia.

The main questions it aims to answer are:

* Is intrathecal morphine more effective than TAP block in reducing postoperative somatic pain at rest?
* Does intrathecal morphine differ from TAP block in terms of adverse events, pain during mobilization, visceral pain, rescue analgesic use, maternal satisfaction, and newborn wellbeing?

Researchers will compare the intrathecal morphine (ITM) group to the TAP block (TB) group to see if ITM provides superior analgesia and improved secondary outcomes.

Participants will:

* Undergo spinal anesthesia with hyperbaric bupivacaine and sufentanil
* add 30 μg intrathecal morphine (only ITM group)
* receive bilateral ultrasound-guided TAP block with 20 ml ropivacaine 0.25% and 75 μg clonidine per side (only TB group)
* receive standardized postoperative analgesia with paracetamol, ibuprofen, and tramadol as needed
* be monitored postoperatively for pain (somatic and visceral, at rest and with movement), adverse events, mobilization, maternal satisfaction, and newborn outcomes at regular intervals for 24 hours

This is a single-center, pilot, single-blind trial involving 100 participants (50 per group).

Eligibility

Primary outcome measure(s)

• The primary object is to determine if, in elective cesarean section performed under neuraxial anesthesia, low dose morphine as intrathecal adjuvant is superior to TAP Block using ropivacaine and clonidine in terms of postoperative pain — From enrollment to 24 hours after spinal anesthesia
  The primary endpoint of this trial is the determination of how many times somatic Visual Analogue Scale (or VAS, from worst 0 to best 10) at rest is 6 or more in the different evaluations at 12 AM, 6 PM, 00 AM (or at 6 PM, 00 AM and 6 AM if the cesarean section is performed after 12 AM) and at 24 hours from the spinal anesthesia.

Trial sites (1)

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